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EC number: 210-890-4 | CAS number: 625-36-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In an in vitro mammalian chromosome aberration test the test substance was found not to be clastogenic in human lymphocytes. In an Ames test, the test substance proved mutagenic with and without metabolic activation. In an E.coli SOS chromotest without metabolic activation the test substance was also tested positve for genetic toxicty. A structural analogue of the test substance also proved to be mutagenic using Salmonella typhimurium (TA 100) without metabolic activation.
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- lymphocytes: human (from heparinized human venous blood)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat S-9 mix
- Test concentrations with justification for top dose:
- 5, 10, 20, 40 and 60 µg/mL (without activation system), 60, 125, 250, 500, 750 µg/mL (with activation system)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: culture medium
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.1 µg/mL
- Positive control substance:
- mitomycin C
- Remarks:
- without S-9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5 µg/mL
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S-9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 48 hours
- Exposure duration: Without metabolic activation: 24 hours; With metabolic activattion: 24 hours (After about 3 hours of incubation at 37°C, cells were washed twice with unsupplemented culture medium and then re-incubated in complete culture medium for further 21 hours).
- Fixation time (start of exposure up to fixation or harvest of cells): 72 hours
SPINDLE INHIBITOR: colcemid
STAIN: Giemsa/Titrisol solution
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 100 metaphases
DETERMINATION OF CYTOTOXICITY: mitotic index - Evaluation criteria:
- As a rule, 100 metaphases of each culture for the test substance, negative and solvent controls or 50 cells of each culture for the positive controls were analyzed for chromosome aberrations. A test substance was positive in this test if it led to a biological significant increase in the number of aberrant metaphases incl. and excl. gaps when compared to the untreated control or to the historical control.
- Statistics:
- The statistical evaluation of the data was carried out using the MUCHAN program system (BASF SE).
For each group the proportion of metaphases with aberrations was calculated.
A comparison of each dose group with the negative control group was carried out using Fisher's exact test for the hypothesis of equal proportions. This test was Bonferoni-Holm corrected over the dose groups separately for each time point and was performed one-sided. - Species / strain:
- lymphocytes: human (from heparinized human venous blood)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- According to the results of the present study, the test substance did not cause a biological significant increase in the number of aberrant metaphases incl. and excl. gaps when compared to the untreated control or to the historical control data (2.0 - 12.0% incl. gaps or 0.5 - 4.0% excl. gaps).
No differences regarding aneuploidies (hyperploid metaphases) and polyploidies between the varous dose groups and the negative control were observed. - Remarks on result:
- other: all strains/cell types tested
Reference
Additional information
In an in vitro mammalian chromosome aberration test performed similar to OECD guideline 473 (1991; RL1), the test substance was tested for the ability to induce chromosomal aberrations in human lymphocytes following exposure in the presence and absence of a metabolizing system (Aroclor 1254 induced rat S-9 mix). In the absence of S-9 mix the test concentrations were 5, 10, 20, 40 and 60 µg/mL and with S-9 mix 60, 125, 250, 500, 750 µg/mL. For control purposes, negative controls (untreated) and positive controls: mitomycin C and cyclophosphamide were tested. The test substance did not cause an increase in the number of aberrant metaphases incl. and excl. gaps either without S-9 mix or after adding a metabolizing system. Thus, under the experimental conditions chosen here the test substance has no chromosome-damaging (clastogenic) effect in vitro using human lymphocytes.
An Ames test (OECD TG 471, GLP) is available in which the tester strains Salmonella typhimurium TA 1535, TA 1537, TA1538, TA 98 and TA 100 were used to examine the mutagenic potential of the test substance up to concentrations of 5000 µg/plate in a standard plate test with and without metabolic activation (1991; RL2). In the strains TA 1535, TA 1537 and TA 100 a concentration-dependent increase in revertants both with and without metabolic activation was observed. For TA 1535 the increase was already observed at the lowest concentration (10 µg/plate). For the other 2 strains the lowest effective concentration was 100 µg/plate. The test substance thus proved to be mutagenic in this test system.
The test substance was also tested, without metabolic activation, in the E.coli SOS chromotest (Szegedi 1998, abstract only, RL4). The experiments were carried out with a BIOSCREEN Analyzing System using the BIOSOS program (LABSYSTENS Ltd.). The test substance tested positve for genetic toxicty under the experimental conditions chosen here.
As a structural analogue of the test substance: 3-chloropropionic acid, CAS no. 107 -94 -8 (hydrolysis product of 3 -chloropropionyl chloride, CAS no. 625 -36 -5) was tested in a reverse mutation assay (Ames test) using strains of Salmonella typhimurium (TA 100 and 1535) in the presence and absence of metabolic activation (1987; RL2). Tested concentrations were 50, 100, 250, 500 and 1000 µg/plate. Only the results of the TA 100 strain without metabolic activation were presented in the paper. The test substance was mutagenic, yielding 1000 revertants/250 µg.
Justification for classification or non-classification
Based on the available information, classification for genetic toxicity is not possible in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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